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Clinical Trials/EUCTR2011-005868-25-Outside-EU/EEA
EUCTR2011-005868-25-Outside-EU/EEAActive, not recruitingNot Applicable

A randomised, open-label study to assess the immunogenicity and reactogenicity of GSK Biologicals’ DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course at 2-3-4 or 3-4-5 months of age in healthy infants in China. - DTPA-IPV (INFANRIX-IPV)-056

GlaxoSmithKline Biologicals0 sites985 target enrollmentStarted: June 1, 2015Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
985
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit.
  • •Born after a gestation period of 36 to 42 weeks, inclusive.
  • •Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
  • •Written informed consent obtained from the parent(s) or LAR(s) of the subject.
  • •Healthy subjects as established by medical history and clinical examination before entering into the study.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 985
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • •Child in care.
  • •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
  • •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • •Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period with the exception of hepatitis B vaccine.
  • •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • •Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and/or Hib disease or vaccination.
  • •History of seizures or progressive neurological disease.
  • •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • •Major congenital defects or serious chronic illness.
  • •The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
  • •Current febrile illness or axillary temperature > 37.00°C or other moderate to severe illness within 24 hours of study vaccine administration.

Investigators

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